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EHR stakeholder workshop – 11th October 2007 1 EHR integration for clinical research: toward new interaction models ? Isabelle de Zegher.

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Presentation on theme: "EHR stakeholder workshop – 11th October 2007 1 EHR integration for clinical research: toward new interaction models ? Isabelle de Zegher."— Presentation transcript:

1 EHR stakeholder workshop – 11th October EHR integration for clinical research: toward new interaction models ? Isabelle de Zegher

2 EHR stakeholder workshop – 11th October Hospital Clinical Care and Clinical Research 2 separate electronic worlds…. Hospital GPs Office Pharma Industry GPs Office Hospital GPs Office EDC (electronic data capture)

3 EHR stakeholder workshop – 11th October Hospital GPs Office Pharma Industry GPs Office Hospital GPs Office EDC (electronic data capture) Patient recruitment Clinical trial simulation Pharmacovigilance Predictive safety Pharmaco-economics Pharmaceutical/disease management ePrescribing New indication identification Personalized medicine Clinical Care and Clinical Research..who will benefit from electronic data exchange

4 EHR stakeholder workshop – 11th October Potential use cases for EHR Source: Splitstream project

5 EHR stakeholder workshop – 11th October Organizational aspects of EHR integration Technology is necessary but not sufficient Benefits of EHR integration for clinical research are MAJOR; but costs ALSO –No documented business case yet –No quick wins, but some use cases more feasible Interaction one hospital/one sponsor is not affordable in production –n to m interfaces needed –OR standard based data exchange –OR third party ?

6 EHR stakeholder workshop – 11th October Questions How to adapt interaction models & processes to ensure benefit at affordable cost –Internal processes changes in providers & sponsors ? –New roles ? –New actors (third party ? IT vendors as enablers ? ) How to build a common vision across HealthCare to implement these change –Shared understanding –Communication forum ?

7 EHR stakeholder workshop – 11th October Focus : Patient Recruitment Scope Potential changes –New roles and processes Structured protocol generation & checks before trial Increase IT skills/collaboration –Third party: which type, which services ? Decrease constraints related to privacy issues Decreased cost of technical integration Provide additional services (act on behalf of caring physician,…) to speed process Protocol feasibility Investigator enrollment Patient enrollment

8 EHR stakeholder workshop – 11th October Focus: Data Collection Scope/Issues –~80% data collected in clinical care can be re-used –Additional data: integration & ownership ? Potential changes –New roles and processes Integration of clinical care and clinical research processes in provider organization ? How to seamlessly adapt EHR for new data acquisition ? Role of CRA versus investigator ? –Third party: which services ? Decrease costs related to technical integration New type of CRO ?

9 EHR stakeholder workshop – 11th October Focus : Safety Scope –pre-launch versus post-launch –Signal detection versus Adverse Events reporting Potential changes –New roles and processes validated information on drugs to ensure correct imputation Predictive safety: Data mining within existing EHR databases: which skills, which process Different collaboration mode: sponsors working directly with providers (no need for data exchange) Impact on pharmacovigilance ?

10 EHR stakeholder workshop – 11th October Building Recommendations Expected deliverable –Issues with current interaction model –Proposal to accelerate effective/secure interaction –Practical next steps Note: assumption for this stream is that technical and legal hurdle can/will be solved

11 EHR stakeholder workshop – 11th October Program – Thursday Afternoon

12 EHR stakeholder workshop – 11th October Program – Friday Morning


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